NCT04433052 Clinical Value and Cost-effectiveness of a Personalized Prevention Program (PPP) in Patients With High Risk Stable CHD
| NCT ID | NCT04433052 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Tampere University |
| Condition | Coronary Heart Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 12,000 participants |
| Start Date | 2023-02-01 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 12,000 participants in total. It began in 2023-02-01 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Prospective clinical study with two parts: PART A: a prospective biomarker-based risk screening study in coronary heart disease (CHD) subjects PART B: a nested randomized clinical trial (RCT) in an enriched subpopulation of high-risk stable CHD subjects PART A: 12 000 subjects with stable CHD PART B: 2000 subjects with high risk of CV events will be randomized to usual care (UC) or personalised prevention program (PPP) i.e. 1000 subjects per arm. Study purpose is to assess the clinical value and cost-effectiveness of a personalised prevention program (PPP) in high-risk, stable coronary heart disease (CHD) subjects and to prospectively validate risk screening biomarkers
Eligibility Criteria
Eligible study subjects must meet all of the following inclusion criteria: 1. Informed consent form signed by the study subjects. 2. Male or female aged 30 to 80 years on the day of enrolment. 3. \> 50% stenosis in one or more major coronary arteries on angiography or computerised tomography (CT) performed within the preceding one year (from enrolment visit). or Myocardial infarction (type I, II) during the preceding year. Eligible study subjects must not meet any of the following exclusion criteria: 1. Hospitalisation for acute coronary syndrome, myocardial infarction, stroke, coronary revascularisation or acute heart failure within the preceding one month (30 days). These subjects can be enrolled after a one-month stabilisation period, which begins from the time of the event. 2. Subjects with NYHA class III-IV heart failure i.e. marked limitation in activity due to symptoms, comfortable only at rest. 3. Uncontrolled arrhythmias such as ventricular tachycardias. 4. Subjects undergoing dialysis due to severe renal disease. 5. Diseases that severely disable exercising (per investigator's judgement), such as rheumatoid arthritis, neurological or orthopaedic diseases. 6. Known aplastic or haemolytic anaemia. 7. Concomitant non-coronary disease, such as malignancy that limits life expectancy to less than three years. 8. Concurrent participation in another interventional study. 9. Subjects not able and/or willing to attend all scheduled visits and comply with all study procedures and use a smartphone application.
Contact & Investigator
Reijo Laaksonen, MD, PhD
STUDY DIRECTOR
Tampere University
Frequently Asked Questions
Who can join the NCT04433052 clinical trial?
This trial is open to participants of all sexes, aged 30 Years or older, up to 80 Years, studying Coronary Heart Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04433052 currently recruiting?
Yes, NCT04433052 is actively recruiting participants. Contact the research team at hanna.marttila@tuni.fi for enrollment information.
Where is the NCT04433052 trial being conducted?
This trial is being conducted at Helsinki, Finland, Helsinki, Finland, Kuopio, Finland, Oulu, Finland and 11 additional locations.
Who is sponsoring the NCT04433052 clinical trial?
NCT04433052 is sponsored by Tampere University. The principal investigator is Reijo Laaksonen, MD, PhD at Tampere University. The trial plans to enroll 12,000 participants.